UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023475 |
|---|---|
| Receipt number | R000027011 |
| Scientific Title | A Study on the Effect of Food Containing Pueraria Flower Extract on Visceral Fat Area and Liver Function Enzyme -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- |
| Date of disclosure of the study information | 2016/08/05 |
| Last modified on | 2020/05/08 12:54:46 |
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Basic information
Public title
A Study on the Effect of Food Containing Pueraria Flower Extract on Visceral Fat Area and Liver Function Enzyme
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym
The Effect of Food Containing Pueraria Flower Extract on Visceral Fat Area and Liver Function Enzyme
Scientific Title
A Study on the Effect of Food Containing Pueraria Flower Extract on Visceral Fat Area and Liver Function Enzyme
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym
The Effect of Food Containing Pueraria Flower Extract on Visceral Fat Area and Liver Function Enzyme
Region
| Japan |
Condition
Condition
No (Subjects with normal liver function whose BMI are 23 or over and under 30)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of food containing pueraria flower extract on visceral fat area and liver function enzyme
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area
Liver function enzyme
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Food containing pueraria flower extract
Interventions/Control_2
Food not containing pueraria flower extract
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females aged 20 to 64 years old.
(2) Subjects whose AST and ALT are up to 50 U/L, and gamma-GTP are up to 100 U/L(males) or 60 U/L(females).
(3) Subjects whose BMI are 23 or over and under 30.
(4) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
(1) Subjects who use oral medications affecting obesity, hyperlipidemia, lipid metabolism, liver function, and so on.
(2) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses and/or Foods with Function Claims) affecting obesity, hyperlipidemia, lipid metabolism, liver function, and so on during test periods.
(3) Subjects who can't stop drinking from 2 days before each measurement.
(4) Subjects who contract, are under treatment for or have a history of liver disease.
(5) Subjects who contract or are under treatment for serious diseases (e.g., kidney disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disorder).
(6) Subjects who have declared allergic reaction to ingredients of test foods.
(7) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
(8) Subjects who have implanted metal in the abdominal area, as detected by computerized tomography.
(9) Subjects who have implantable medical devices (e.g., cardiac pacemaker and/or implantable defibrillator).
(10) Subjects who have claustrophobia.
(11) Subjects who are shiftworker and/or midnight-shift worker.
(12) Subjects who have been diagnosed as familial hyperlipidemia.
(13) Subjects who are planning to become pregnant after informed consent for the current study, are pregnant or lactating.
(14) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study.
(15) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Nakamura |
Organization
HigashiKoganei Sakura Clinic
Division name
Internal Medicine
Zip code
184-0011
Address
4-37-26 Higashi-cho, Koganei-shi, Tokyo
TEL
042-382-3888
kunitachisakura01@gmail.com
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6205-6222
suda-clinic_irb@imeq.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 05 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000027011
Publication of results
Published
Result
URL related to results and publications
http://www.medicalonline.jp/journal/info?GoodsID=ef4oyoya/2017/009203/005&name=0091-0102j
Number of participants that the trial has enrolled
130
Results
Statistically significant difference was confirmed in the Visceral fat area.
Statistically significant difference was not confirmed in the Liver function enzyme.
Results date posted
| 2020 | Year | 05 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Males and females aged 20 to 64 years old.
Participant flow
Enrolled(n=130)
Completed(n=125)
Analysed(n=111)
Adverse events
No adverse events were observed that be related to test food.
Outcome measures
Visceral fat area
Liver function enzyme
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 04 | Day |
Last modified on
| 2020 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027011
